More Deaths May be Linked to Controversial Blood Thinner Heparin

Heparin, the blood-thinning drug that has been blamed for as many as 100 patient deaths and more injuries caused by contaminated ingredients and confusing labeling that led to overdoses, may be involved in the deaths of two patients in Delaware.

Baxter International Inc., the maker of heparin, has confirmed that a 71-year-old man and a 64-year-old woman who received the drug at Beebe Medical Center in Lewes, Del. have died. A third patient who suffered medical complications at the same hospital after receiving the drug survived.

Since all three patients were being treated with Baxter heparin, officials suspect the drug may be involved, although no direct link to heparin has yet been established. Hospital officials informed Baxter about the deaths and the Food and Drug Administration is investigating.

Contaminated Heparin Blamed for Deaths, Injuries

In 2008, Baxter heparin contaminated with a counterfeit active ingredient supplied by a Chinese company was blamed for about 100 deaths and hundreds of injuries to patients receiving the drug. Based on those injuries, the FDA ordered a recall of heparin made by Baxter in March 2008.

The ingredient, over-sulfated chondroitin sulfate, was designed to fool quality-control testing by mimicking the authentic active ingredient in heparin, but patients suffered deadly and severe complications from the drug. It later was determined that the FDA had failed to inspect the Chinese plant where the contaminated heparin was made, prompting calls to improve the agency’s monitoring of foreign drug manufacturers.

In March 2009, dozens of people filed a class-action lawsuit against Baxter for injuries allegedly caused by the contaminated heparin. The patients’ lawsuit sought unspecified financial damages and other relief.

Differences Found With 2008 Heparin Outbreak

Officials were quick to distinguish the latest heparin patient deaths in Delaware from last year’s heparin scare. Unlike in 2008, when the contaminated heparin was delivered in vials and bulk supplies, the new cases stem from patients being treated with pre-mixed intravenous bags of heparin, officials said. Also, the products were not made in China and did not use ingredients contributed by firms in that country. The bags of intravenous heparin are made in North America, the FDA said.

Also, testing of the patients who died and the third sickened after being treated with heparin did not detect the same contaminant that was found in the 2008 deadly outbreak, officials said. Another key difference between the heparin outbreak and the most recent patient deaths is that the latest incidents involved patients suffering inter-cranial bleeding. In the 2008 outbreak of contaminated heparin, the patients suffered severe allergic reactions and heart complications.

Labeling Also Blamed for Heparin Injuries

Heparin contaminated with a counterfeit active ingredient was not the only source of controversy for Baxter heparin in 2008. The drug maker also was criticized for labeling that failed to adequately distinguish between full-strength heparin and a lower-dose form of the drug, called HepLock, which is used in newborns.

Confusion between the size of the vials and similar labeling for heparin and HepLock was blamed for mix ups in which newborns were given multiple doses of full-strength heparin instead of HepLock, causing deadly internal bleeding. In one high-profile case, the newborn twins of actor Dennis Quaid and his wife were critically injured when a nurse at Cedars-Sinai Medical Center in Los Angeles mistakenly administered several doses of heparin to the twins instead of HepLock. The twins survived, but Quaid has since testified before Congress about the need to revise the labeling for heparin and HepLock.

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